Transcript CAHCOPS2015PART1of3 - Arkansas Hospital Association

Critical Access Hospitals (CAH)
What every CAH needs to know about the
Conditions of Participation (CoPs)
Speaker
Sue Dill Calloway RN, Esq.
CPHRM, CCMSCP
AD, BA, BSN, MSN, JD
President
Board Member
Emergency Medicine Patient
Safety Foundation
www.empsf.org
614 791-1468
[email protected]
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You Don’t Want One of These
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Mandatory Compliance
Hospitals that participate in
Medicare or Medicaid must
meet the Conditions of
Participation (COPs) for all
patients in the facilities and not
just those who are Medicare or
Medicaid patients,
Hospitals accredited by the
Joint Commission (TJC), AOA,
CIHQ, or DNV Healthcare have
what is called deemed status,
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CAH Problematic Standards
Date and time on all orders and entries
Verbal orders, Cluttered hallways
H&Ps, Life safety code issues, EMTALA,
Informed consent, Cleanliness of dietary
Plan of care, Privacy and whiteboard,
Handling, dispensing, storage and
administration of medications
Meeting the nutritional needs of patients
Healthcare services in accordance with P&P
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CAH Problematic Standards
Medical record documentation must reflect
the nursing process, Timing of medications
Legibility of the medical record, No orders
Equipment and supplies used in life saving
procedure, Hand Hygiene & Gloving
R&S for PPS hospitals but CAH still need to
do something, Failure to Monitor Patient for
Safety (Suicide Precautions)
Infection control issues are big
What else should we add???
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Access to Hospital Complaint Data
CMS issued Survey and Certification memo
on March 22, 2013 regarding access to
hospital complaint data
Includes acute care and CAH hospitals
 Does not include the plan of correction but can request
 Questions to [email protected]
This is the CMS 2567 deficiency data and
lists the tag numbers
Updating quarterly
 Available under downloads on the hospital website at www.cms.gov
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Access to Hospital Complaint Data
There is a list that includes the hospital’s
name and the different tag numbers that
were found to be out of compliance
 Many on restraints and seclusion, EMTALA,
infection control, patient rights including
consent, advance directives and grievances
Two websites by private entities also publish
the CMS nursing home survey data
 The ProPublica website for LTC
 The Association for Health Care Journalist (AHCJ)
websites for hospitals
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Access to Hospital Complaint Data
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Updated Deficiency Data Reports
www.cms.gov/Medicare/Provider-Enrollment-andCertification/CertificationandComplianc/Hospitals.html
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Small or Rural Hospitals
American Hospital Association has Web
site with good information for CAH
Has recent issues of interest to CAH
Excellent resources including current list
of all CAHs in the US
Has CAH newsletters
 go to http://www.aha.org/aha/issues/RuralHealth-Care/update-newsletters.html
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AHA CAH Resources
www.aha.org/aha/issues/RuralHealth-Care/updatenewsletters.html
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AHA CAH Resources
www.aha.org/advocacyissues/rural/updatenewsletters.shtml
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AHA Critical Access Website
www.aha.org/aha_app/issues/CAH/index.jsp
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Rural Assistance Center
www.raconline.org
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Rural Assistance Center
www.raconline.org
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CMS Updated Website www.cms.gov
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CMS CAH Website
CMS has a website for resources
Includes:
 State operations manuals
 Program transmittals
 Guidance for laws and regulations for
CAH
 Medicare Learning network
 Other helpful information
 Email questions to [email protected]
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CMS CAH Website
ww.cms.gov/center/cah.asp
http://www.cms.gov/Center/ProviderType/Critical-Access-HospitalsCenter.html?redirect=/center/cah.asp
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The Conditions of Participation CoPs
First, published in the Federal Register
Federal Register available at no charge at
www.gpoaccess.gov/fr/index.html
Next, CMS publishes Interpretive Guidelines
and some include survey procedures,
Current CoP issued Nov 10, 2014
Changes to tag 162 and 226 on January 31, 2014 and April change
from MR/DD to intellectual disability and November 10, 2014 to Tag
222 regarding maintenance and equipment
CMS made many changes effective June 7,
2013 and 93 page memo January 16, 2015
1 www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf
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Subscribe to the Federal Register Free
http://listserv.access.gp
o.gov/cgibin/wa.exe?SUBED1=
FEDREGTOC-L&A=1
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new website at
www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf
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www.cms.gov/manuals/Downloads/som107ap_w_cah.pdf
and is critical access hospital CoPf
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CAH Manual 236 Pages
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93 Page Memo January 16, 2015
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January 16, 2015 Memo
93 pages long and advance copy
Changes to pharmacy, infection control,
dietary, nursing, and rehab services
To reflect changes effective July 11, 2014
including responsibilities of physicians
 MD or DO needs to review non-physician
outpatient order only if required by state law or
where a co-signature is required
 Physician does not need to visit at least every two
weeks the CAH
 P&P committee does not need outside person
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January 16, 2015 Memo
Major changes to pharmacy and nursing
standards and add rehab
CMS now has an email address that
questions can be addressed
 [email protected]
Amends 31 tag numbers
 211, 260, 261, 270-284, 286-299
Changes are shown in red
Advance copy and may see some minor
tweaking with final copy
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CAH Services Direct Services or Contracts
CMS published more than 2 dozens changes
to the hospital CoP in FR on May 16, 2012
and went into effect June 7, 2013
Several that impact CAHs
Currently. The CAH CoP requires that certain
types of services be provided directly rather
than through contracts or under arrangements
 This included diagnostic and therapeutic
services, lab and radiology services, and
emergency procedures
 CMS eliminated this requirement
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Final Federal Register Changes
www.ofr.gov/(S(5jsvvwmsi4nfjrynav20ebeq))/OFR
Upload/OFRData/2014-10687_PI.pdf
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How to Find Changes
 Have one person in your facility who goes out to
this website once a month and checks for updates,
 www.cms.hhs.gov/SurveyCertificationGenI
nfo/PMSR/list.asp,
 You can do a search for time frame and can add
words to search,
 Click on fiscal year to bring up most current memos
 CMS issues transmittal before putting it into the
CAH Manual
 Person in charge of CAH at CMS is Kianna Banks,
[email protected], 419 786-3498
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CMS Survey and Certification Website
www.cms.gov/SurveyCertific
ationGenInfo/PMSR/list.asp#
TopOfPage
Click on Policy & Memo to
States
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CMS Transmittals
www.cms.gov/Transmittals/01_overview.asp
http
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CMS Memo on Safe Injection Practices
CMS issues a 7 page memo on safe injection
practices
Discusses the safe use of single dose
medication to prevent healthcare associated
infections (HAI)
Notes exception which is important especially
in medications shortages
 General rule is that single dose vial (SDV)can only be used
on one patient
 Will allow SDV to be used on multiple patients if prepared by
pharmacist under laminar hood following USP 797 guidelines
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Safe Injection Practices
http://www.cms.gov/Medicare/ProviderEnrollment-andCertification/SurveyCertificationGenInfo/index.ht
ml?redirect=/SurveyCertificationGenInfo/PMSR/li
st.asp
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CMS Memo on Safe Injection Practices
 All entries into a SDV for purposes of repackaging
must be completed with 6 hours of the initial
puncture in pharmacy following USP guidelines
 Only exception of when SDV can be used on
multiple patients
 Otherwise using a single dose vial on multiple
patients is a violation of CDC standards
 CMS will cite hospital under the hospital CoP
infection control standards since must provide
sanitary environment
 Also includes ASCs, hospice, LTC, home health, CAH, dialysis, etc.
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CMS Memo on Safe Injection Practices
 Bottom line is you can not use a single dose vial
on multiple patients
 CMS has section in IC worksheet on this
 CMS requires hospitals to follow nationally
recognized standards of care like the CDC
guidelines
 SDV typically lack an antimicrobial preservative
 Once the vial is entered the contents can support
the growth of microorganisms
 The vials must have a beyond use date (BUD)
and storage conditions on the label
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CMS Memo on Safe Injection Practices
 Make sure pharmacist has a copy of this memo
 If medication is repackaged under an arrangement
with an off site vendor or compounding facility ask
for evidence they have adhered to 797 standards
 ASHP Foundation has a tool for assessing
contractors who provide sterile products
Go to
www.ashpfoundation.org/MainMenuCategories/Practic
eTools/SterileProductsTool.aspx
 Click on starting using sterile products outsourcing tool
now
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Not All Vials Are Created Equal
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CMS Memo on Insulin Pens
CMS issues memo on insulin pens
Insulin pens are intended to be used on one
patient only
 CMS notes that some healthcare providers are
not aware of this
 Insulin pens were used on more than one
patient which is like sharing needles
 Every patient must have their own insulin pen
 Insulin pens must be marked with the patient’s
name
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CMS Memo on Insulin Pens
Regurgitation of blood into the insulin
cartridge after injection can occur creating a
risk if used on more than one patient
Hospital needs to have a policy and
procedure
Staff should be educated regarding the safe
use of insulin pens
More than 2,000 patients were notified in
2011 because an insulin pen was used on
more than one patient
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CDC issues reminder on same and has free
CDC Reminder on Insulin Pens
www.cdc.gov/injectionsafety/clinical-reminders/insulinpens.html
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CDC Has Flier for Hospitals on Insulin Pens
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VA Alert on Insulin Pens
Pharmacist found several insulin pens not
labeled for individual use
Found used multi-dose pen injectors used on
multiple patients instead of one patient use
New requirement that can only be stored in
pharmacy and never ward stocked
Instituted new education for staff on use
Part of annual competency of staff
Instituted new policy of safe use of pen
injectors
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VA Issues Alert
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VA Alert on Insulin Pens
Decided to prohibit multi-dose insulin pen
injectors on all patient units except the
following:
 Patients being educated prior to discharge to use a
insulin pen injector
 Eligible patient is self medication program
 Patient needing treatment and no alternative
formulation is available
 Patients participating in a research protocol requiring
an insulin pen
 Pen injectors dispensed directly to patients as an
outpatient prescription
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FDA Issues An Alert in 2009
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Insulin Pen Posters and Brochures Available
www.oneandonlycampaign.org
/content/insulin-pen-safety
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Pt Safety Briefs Free at www.empsf.org
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Luer Misconnections Memo
 CMS issues memo March 8, 2013
 This has been a patient safety issues for many
years
 Staff can connect two things together that do
not belong together because the ends match
 For example, a patient had the blood pressure
cuff connected to the IV and died of an air
embolism
 Luer connections easily link many medical
components, accessories and delivery devices
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Luer Misconnections Memo
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PA Patient Safety Authority Article
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June 2010 Pa Patient Safety Authority
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ISMP Tubing Misconnections
www.ismp.org
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TJC Sentinel Event Alert #36
www,jointcommission.org
http://www.jointcommission.org/sentine
l_event_alert_issue_36_tubing_misco
nnections—
a_persistent_and_potentially_deadly_
occurrence/
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Managing Risk During the Transition
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Misconnections & How to Prepare
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CMS Hospital Worksheets History
 October 14, 2011 CMS issues a 137 page memo in the
survey and certification section and it was pilot tested in
hospitals in 11 states
 Memo discusses surveyor worksheets for hospitals by CMS
during a hospital survey
 Addresses discharge planning, infection control, and
QAPI (performance improvement)
 May 18, 2012 CMS published a second revised edition
and pilot tested each of the 3 in every state over summer
2012
 November 9, 2012 CMS issued the third revised
worksheet
 Final ones issued November 26, 2014
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Final 3 Worksheets QAPI
www.cms.gov/SurveyCertificationG
enInfo/PMSR/list.asp#TopOfPage
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CMS Hospital Worksheets
 Will use whenever a validation survey or certification
survey is done at a hospital by CMS for PPS
hospitals
 Not currently being used for CAH
However, highly suggest that every CAH
review and be aware of what is in these three
forms
 Helps to understand how the guidelines are
interpreted
 Especially since infection control standards are very
similar
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CMS Hospital CoPs
Appendix W, Tag C-0150 to C 0408,
See visitation memo adding tag 10001002 which is after tag 298
It is out of order
Interpretive guidelines updated more
frequently now so check monthly for
updates
Manual includes swing beds in CAHs,
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CMS Hospital CoPs
Consider doing a gap analysis,
Take each section and on left hand side of
page document how you comply with each
section,
Time consuming but will have with compliance,
Include policies and yellow section that
corresponds to the required P&P in the CoP
Have one person in charge who can keep up with
changes and who knows what to do if CMS shows
up for validation or complaint survey
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Rehab or Behavioral Health Dept CAH
Remember, CAH can have up to a ten
bed rehab or psych (behavioral health)
unit
If so it is surveyed under the regular
hospital CoP program even though
CAH has a separate manual
It is Appendix A
Last updated September 26, 2014 and
manuals changing frequently so always
check the CMS website
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TJC Revised Requirements
TJC or the Joint Commission (not called
JCAHO anymore) has made many changes
to bring their standards into closer alignment
with CMS
Having less differences is helpful to
hospitals,
Have some that are for hospitals that use
them to get deemed status (DS) or payment
for M/M patients,
 Will specify DS after the standard
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Introduction
 Medicare CoPs are found at 42 CFR Part
485 Subpart F.
Authority to make copies of things is at 42
CFR 489.53,
 Recommend you have surveyor make you a
copy also,
 Please ask surveyor not to make copy of peer
review material-abstract out what is needed,

Can get all CFR now electronically off Internet free at GPO access at
www.gpoaccess.gov

Click on Code of Federal Regulations and can do search or click on e-CFR, or
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl,
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Resources to Keep Handy
Appendix W Hospital CoPs (“C”)
Unless CAH has a separate rehab or behavioral health unit
and then you need Appendix A- Hospital CoP also for these
departments
Survey protocol and module,
Q- Immediate jeopardy.
V-EMTALA,
W-Hospital swing beds-if you have these,
B- Home health
I-Life safety code
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Survey Procedure
The interpretive guidelines provide instructions to
the surveyors on how to survey the CoPs-like
questions to the test,
They have survey procedure instructions to
determine the hospital policy for notifying patients
of their rights,
Ask patients to tell you if the hospital told them
about their rights,
Deficiency citation show how the entity failed to
comply with regulatory requirements and not the
guidelines!
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Survey Protocol
First 26 pages list the survey protocol,
Includes a section on:
Off-survey preparation,
Entrance activities,
Information gathering/investigation,
Preliminary decision making and
analysis of finding,
Exit conference,
Post survey activities,
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Swing Bed Module
When patients need brief transitional care at
the hospital at the end of their acute care stay,
If swing beds then do survey under CAH
swing-bed requirements found at 42 CFR Part
485.645,
Reimbursement is for Skilled Nursing care as
opposed to Acute Care,
 Term is for reimbursement and has no
relationship to geographic location in the
hospital,
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Swing Bed Module
May be in acute care status one day
and then in swing bed status the next
day,
3-day qualifying stay for the same spell
of illness in any hospital or CAH is
required prior to admission to swingbed status for Medicare patients,
Actual swing-bed survey requirements
are referenced in the Medicare Nursing
Homes requirements at 42 CFR Pt 483
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Swing Bed Counts
 Surveyor will verify 25 bed rule,
 Will count inpatient beds but not observation beds,
 Does not count OR, PACU, L&D, newborn nursery
(unless medical treatment) or ED stretchers, sleep
lab beds, exam tables, or observation beds (210),
 Do count birthing beds where patients remain after
giving birth,
 Do not count beds in Medicare certified rehab or
psychiatric distinct part units,
 Will conduct open record review on all swing bed
patients,
 Swing bed deficiencies are documented on a
separate form even though survey done
simultaneously,
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Regulation/Interpretive Guidelines
Starts with a tag number, example C-0150,
C refers to the CAH CoPs,
Recall first is the section from federal
register (CFR)
Then the section called the “interpretive
guidelines”,
Some have a section called “Survey
Procedure” and will explain how it is surveyed
or what policies will be reviewed, what
questions to ask or documents to look at,
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Compliance with Laws C-150
Standard: The CAH must be in
compliance with all federal, state, and
local laws,
Surveyor may interview CEO or other
designated by hospital to determine this,
May refer non-compliance to proper agency
with jurisdiction such as OSHA
 TB, blood borne pathogen, universal
precautions, or EPA (haz mat or waste
issues),
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Advance Directives 151 2013
Standard: CAH must be in compliance with
federal laws and regulations related to the
health and safety of patients
Inpatients and outpatients have the right to
make advance directives
Staff must comply with their advance
directives
Patients have the right to refuse treatment
Make have a DPOA or another person such
as a support person/patient advocate
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Advance Directives 151
May use advance directives to designate a
support person for a person of exercising the
visitation rights
If patient incapacitated and DPOA then must
give this information to make informed
decisions and consent for the patient
CAH must also seek the consent of the
patient’s representative when informed
consent is required for a care decision
 Surrogate decision makers step into shoe of
patient when incompetent
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Advance Directives 151
Must provide advance directive information
to the competent patient when admitted
 Must also give to the outpatient if in the ED,
observation, or same day surgery patient
 Must document you gave it in the medical
record
If incapacitated then to the family or
surrogate
Has conscience objector clause but must still
allow DPOA or support person to make
decision if incapacitated
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Advance Directives 151
Can not require one
Document in the medical record
Must make sure staff is educated on the
P&P
This includes the right to make a psychiatric
advance directive or mental health
declaration
 Should still give consideration even if not a
state specific law
Must provide community education
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Physician Ownership Disclosures 151
Must disclose if physician owned hospital
 This includes ownership by immediate family member and
must be in writing
 If none of physician owner refer then the hospital must sign
attestation to this effect
 Physicians must also disclose to patients who
they refer
 This must be as a condition for getting MS
privileges
 Disclose in writing if physician not on premise 24
hours a day for emergencies
 Sign acknowledgement if patient admitted
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Compliance with Laws/Licensure
Standard: Patient care services must be
provided with in accordance with laws (152),
Ensure delegation as allowed by law,
Ensure practicing according to scope of
practice, such as NP, CNS, PA,
Standard: Hospital must be licensed (153)
Personnel must be licensed or certified if
required by state (Tag 154: doctors, nurses, PT,
PA, OT, x-ray tech. et. al.),
Review sample of personnel files and make sure
credentials and licensure is up to date,
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Status/Location 160
If CAH moves then status and location
must be reassessed
 Harder to relocate now, See tag 166 on
relocation
Many changes to relocation and allows
for grandfathering (see SOM Manual 2)
Criteria for determining mountainous
terrain, revised definitions of primary
and secondary roads, documentation
needed to relocate CAH and 75% rule,
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Status and Location
160-162 2013
CAH must meet the location requirements at
the time of the initial survey (160)
Compliance is reconfirmed at the time of
every subsequent full survey
Tag 162 discusses information regarding if
the CAH has been classified as an urban
hospital
Discusses CAH located outside any area that
is a metropolitan statistical area
CAH must be in a rural area
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Q&A
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Location in a Rural Area 8-30-13
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Agreement with Network Hospitals 191
Standard: CAH that is a member of a rural
network must have agreement with at least
one hospital that is a member of the
network
A CAH must develop agreements with an
acute care hospital related to patient
referral and transfer, communication,
emergency and non-emergency patient
transportation
Will ask how CAH communicates with other
hospitals- do you keep a communication log?
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Working with the Other Hospital
What P&P related to communication
system?
Will review any written agreements with
local EMS
Need to provide for transport between
the two facilities
Do the two hospitals have electronic
sharing of patient data, telemetry and
medical records? (193)
87
Credentialing and QA Agreement 195
Standard: The CAH has to have an
agreement with a hospital that is a member
of the network or QIO for quality
improvement and credentialing
 State networking requirements vary
 Agreement for QA need to include a medical
record review as part of quality and to establish
medical necessity of care at CAH,
 Surveyor will review P&P to determine how
information is obtained, used and how
confidentiality is maintained,
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Telemedicine Agreements C&P 196
Standard: Agreements for C&P Telemedicine
Physicians
 Board must make sure agreement with distantsite hospital (DSH) or distant-site telemedicine
entity (DSTE)
 Decide what category of practitioners are eligible
for appointment to the MS
 Board appoints with recommendation of the MS
 Board approves the MS bylaws and other MS
rules and regulations
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Telemedicine December 22, 2011
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Agreements for C&P 196
Make sure MS is accountable to the board
for quality of care provided to the patients
Must have and follow criteria for selection of
MS that is based on individual character,
competence, training, experience, and
judgment
Make sure under no circumstance is
privileges based solely on certification,
fellowship, or membership in a special body
or society
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Telemedicine C&P
197
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Emergency Services 200
Standard: Must provide emergency care
necessary to meet the needs of its inpatients
and outpatients,
The ED cannot be a provider-based off-site
location,
Must comply with acceptable standards of
practice,
Including those established by national
professional organizations such as ACEP, ENA,
ACS, ANA, AMA, American Association for
Respiratory Care,
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Emergency Services
Need qualified medical director,
MS must have P&P regarding the care
provided in the ED,
Policies current and revised based on
QA activities,
MS must establish qualifications to get
privileges to provide ED care,
ED must be adequately staffed,
Must have adequate equipment,
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Emergency Services 200
Must determine the categories and
numbers of staff needed in the ED
 MD/DO, RN, ward clerks, PA, NP, EMTs,
The scope of diagnostic and/or
therapeutic respiratory services offered
by the CAH should be defined in
writing, and approved by the medical
staff
 CT scans, venous Doppler's, ultrasound et. al.,
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14 ED Written Policies
P&P must be developed approved by
MS,
And mid-level practitioners who work in
the ED,
Need triage procedures,
Each type of service provided,
Qualifications, education, training, of
personnel authorized to perform
respiratory care services and if
supervision is needed,
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ED Written Policies
• Equipment assembly and operation;
• Safety practices, including infection control
measures;
• Handling, storage, and dispensing of
therapeutic gases;
• Cardiopulmonary resuscitation;
• Procedures to follow in the advent of
adverse reactions to treatments or
interventions;
• Pulmonary function testing;
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ED Written Policies
• Therapeutic percussion and vibration;
• Bronchopulmonary drainage;
• Mechanical ventilatory and oxygenation
support;
• Aerosol, humidification, and therapeutic
gas administration;
• Administration of medications; and
• Procedures for obtaining and analyzing
ABGs.
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ED Staff Training
Surveyor will interview ED staff to make sure
knowledgeable including (so include in
education of ED staff):
1. Parenteral administration of electrolytes,
fluids, blood and blood components;
2. Care and management of injuries to
extremities and central nervous system;
3. Prevention of contamination and cross
infection; and
4. Provision of emergency respiratory
services.
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EMTALA and ED 24 hours
Must still meet EMTALA (anti-dumping)
requirements,
Revised July 16, 2010 into 68 pages,
Must have 24 hour ED services available,
A CAH without inpatients is not required to
have emergency staff on site 24 hours a day
(If no patients, CAH may close),
Can have NP, PA, or MD on site within 30
minutes,
100
EMTALA, CAH & Telemedicine Memo
CMS welcomes the use of telemedicine by
CAH
CAH not required to have a doctor to
appear when patient comes to the ED
PA, NP, CNS, or physician with
emergency care experience must show up
within 30 minutes
If MD/DO does not show up must be
immediately available by phone or radio
contact 24 hours a day
101
CMS S&C Memo EMTALA & CAH
102
Availability of Drugs 201
CAH must maintain the types, quality and
numbers of supplies, drugs and
biologicals, blood and blood products,
and equipment,
Required by state and local law and in
accordance with accepted standards of
practice,
Surveyor will ask how you make sure
equipment, supplies, and medications are
always available,
103
Emergency Drugs 203
Drugs used in life-saving procedures,
includes;
Analgesics, local anesthetics, antibiotics,
anticonvulsants, antidotes and emetics,
serums and toxoids, antiarrythmics, cardiac
glycosides, antihypertensive, diuretics, and
electrolytes and replacement solutions.
Know how you maintain your inventory
and how drugs are replaced,
104
Emergency Equipment 204
Equipment and supplies commonly
used in life-saving procedures,
includes;
 Airways, endotracheal tubes, ambu
bag/valve/mask, oxygen, tourniquets,
immobilization devices, nasogastric tubes,
splints, IV therapy supplies, suction machine,
defibrillator, cardiac monitor, chest tubes, and
indwelling urinary catheters.
105
Emergency Equipment 204
Make sure staff know where the
equipment is located,
Know how supplies are replaced and
who is responsible for doing this,
Will examine sterilized equipment for
expiration dates,
Will check for equipment maintenance
schedule (defibrillator),
106
Blood and Blood Products 205
Need services for the procurement,
safekeeping, and transfusion of blood,
including the availability of blood
products needed for emergencies on a
24-hours a day basis ,
No requirement to store blood on site,
Can provide in emergency directly or through
arrangement,
Some cases more practical to transport
patient to where the blood is,
107
Blood and Blood Products
If CAH does tests on blood will be surveyed
under CLIA if tests are done,
If collecting blood you must register with the
FDA,
If only storing blood for transfusion and
refers all tests to outside lab then not
performing test as defined by CLIA,
Need agreement in writing regarding the
provision of blood between CAH and testing
lab,
108
Blood and Blood Products
Blood must be appropriately stored to
prevent deterioration,
If types and cross matches must have
necessary equipment
Or can keep 4 units O Neg on hand at
all times,
Release to give, signed by doctor, is
needed if not cross matched when
indicated in an emergency
109
Blood Storage 206
Blood storage must be under the
control and supervision of a
pathologist or other qualified doctor,
If blood banking done under
arrangement, the arrangement has
to be approved by MS and
administration,
Will look for an agreement,
110
Staffing Personnel 207
Must have practitioner (physician, PA,
NP) with training in emergency care on
call and immediately available within 30
minutes,
60 minutes if CAH in frontier area (with less than 6
residents per sq. mile and area meets criteria for
remote by the state and CMS) and state
determines longer time than 30 minutes needed is
only way to provide care,
Will review call schedules,
Will ask staff if they know who is on call,
111
Staffing Personnel 207
 Will review documentation that PA, NP, or MD was
on site within this time frame,
 RN will satisfy this if for temporary period and CAH
has less than 10 beds and is in frontier area (state
governor has to sent letter to CMS as part of rural
health plan),
 CAH must submit this letter to surveyor and
demonstrate shortage and unable to provide,
 Also if state law has more stringent staffing
requirements, like MD on duty 24 hours, must
follow,
 See CMS Memo
112
Coordination with EMS 209
 Must coordinate with EMS,
 Have a procedure where available by
phone or radio on 24 hour basis to
receive calls,
 Should have policies and procedure in
place to ensure MD/DO is available by
phone or radio contact,
 And when emergency instructions are
needed,
113
25 Available Beds 211 2015
CAH maintains no more than 25 acute
care inpatient beds at any one time
 Doesn’t include observation beds, sleep
studies or ED
Any of the inpatient 25 beds can be used to
provide acute or long term care (swing beds)
dependent on patient need
Does not count if CAH has up to 10 bed
rehab unit or behavioral health unit
Average basis of 96 hours per patient,
114
Observations/LOS 211 2015
Previously, could not operate distinct units,
Observations stay is usually not more than 48
hours, unless more strict state limit of 24 hours,
Rewrite your policy on observation beds to meet
this section and the 2 midnight rule,
They do not count observation beds in 25 bed
count now or in calculating average LOS,
 Make sure you are using appropriately,
See the CMS memo on the two midnight rule and
2015 changes
 Place in an outpatient observation bed
 Admit as an inpatient to telemetry
115
116
Two Midnight Rule
 Need an order and need to document medical
necessity
 For inpatient CAH services only, the physician must
certify that the beneficiary may reasonably be
expected to be discharged or transferred to a
hospital within 96 hours after admission to the
CAH.
 Time as an outpatient at the CAH does not count
towards the 96 hours requirement.
 The clock for the 96 hours only begins once the individual is
admitted to the CAH as an inpatient.
 Time in a CAH swing-bed also does not count towards the 96 hour
inpatient limit.
117
Observations 211
Have specific criteria for placing patient in
and discharging from observation
Inappropriate use of observation beds
subjects Medicare beneficiary to increased
coinsurance liability
 20% of CAH customary charges then if properly
admitted as inpatient,
Observation is not appropriate for :
 Substitute for inpatient admission
 For continuous monitoring
 Medically stable patients who need diagnostic testing or
outpatient procedure (blood chemo, dialysis)
118
Observation Not Appropriate
Patients awaiting nursing home placement
For convenience to the patient or family
For routine prep or recovery prior to or after
diagnostic or surgical services
As a routine stop between the ED and
inpatient admission
No prescheduled observations services
Observation services begin and end with the
order of the physician
119
Observation 211
Must provide documentation to show that
observation bed is not an inpatient bed
Need specific criteria for observation
services
Must be different than inpatient criteria
10 bed observation unit might be
disproportionately large
Surveyor might determine observation is
actually inpatient overflow unit
120
Don’t Count in 25 Bed Count 211
Exam or procedure tables
Stretchers
OR tables and PACU bed
Newborn bassinets and isolettes for well baby
boarders unless baby held for treatment
 OB beds if active labor but do count birthing
rooms where patient stays after giving birth
ED carts
 10 bed distinct unit rehab or behavioral health
121
Beds/ LOS Hospice 211
Observation starts and ends with order
 No standing orders for observation
Hospice beds can be dedicated are also
counted as part of the 25 beds,
 Except 96 hour average LOS rule does not
apply,
Medicare does not reimburse the CAH for
hospice patients only the Hospice,
So the CAH has to negotiate payment from
the hospice through an agreement,
122
Length of Stay 212
That does not exceed, on an annual
average basis, 96 hours per patient,
State Fiscal Intermediary (FI) will
determine compliance with this CoP,
 Calculate the CAH’S length of stay based
on patient census data,
 If CAH exceeds the length of stay limit,
the FI will send a report to the CMS-RO
as well as a copy of the report to the SA,
CAH will have to do plan of correction,
123
Construction
6-7-2013
Standard: CAH is constructed, arranged, and
maintained to ensure access to and safety
of patients
Additionally, it must provide adequate space
to provide care to patients
Must be constructed in accordance with state
and federal law
Will look to see if maintained in a manner to
ensure safety of patients
 Conditions of ceilings, walls, and floors
124
Physical Environment
222 2014
Must have housekeeping and preventative
maintenance programs,
All essential mechanical, electrical, and patient-care
equipment is maintained in safe operating condition
These means facilities, supplies and equipment
must be maintained,
How do you ensure your equipment is maintained
properly
 Boilers, elevators, air compressors, ventilators,
X-ray equipment, IV pumps, stretchers, IV
equipment, air compressors, elevators, maintenance log,
125
CMS Hospital Equipment Maintenance
126
Equipment Memo August 2014
127
Equipment Memo Nov 10, 2014
 Make sure maintenance is aware of 15 page
equipment memo which became effective Nov 2014
 Discusses preventive maintenance and inspection
of equipment
 As recommended by the manufacturer or based on a
risk-based assessment unless federal or state law of
CoP specifies otherwise
 Discusses alternative equipment maintenance
(AEM) program
 Must demonstrate that qualified personnel are
performing risk based assessments, PM, or establishing
the AEM program
128
Equipment Memo PM
 To comply consider the following:
 Maintain a written inventory of all medical
equipment or written inventory of selected
equipment categorized by risk assessment
 Such as life support equipment
 Identify high risk medical equipment on the inventory
for which there is a risk of serious injury or death
should it fail such as life support equipment
 Staff must be qualified to perform
 Identify in writing how to maintain, inspect, and test
the medical equipment on the inventory
129
Equipment Memo
 Make sure the frequency is in accordance with
manufacturers recommendation or with strategies
of an alternate equipment maintenance (AEM)
program
 An example for medical equipment is the American
National Standards Institute for the Advancement of
Medical Equipment Handbook
 The frequency in testing, inspecting, and
maintaining must be in accordance with
manufacturers recommendation for the following:
medical device lasers, new medical equipment
with insufficient maintenance history to support use
of AEM, imaging and diagnostic equipment, etc.
130
Disposal of Trash
223
Standard: There is proper routine
storage and prompt disposal of trash,
Includes biohazardous waste,
Must be disposed of in accordance with
standards (EPA, OSHA, CDC, environmental
and safety),
Includes radioactive materials,
Will look for policies for proper storage and
disposal,
131
Storage of Drugs 224
Standard: Drugs and biologicals must
be appropriately stored,
Must be properly locked in the storage area,
 Make sure medication carts in C-section rooms
are locked
 Make sure drugs are not left out in open in tube
system or on dumb waiter ledge
Surveyor will ask what standards,
guidelines, or law you using to make
sure they are stored,
132
Physical Environment 225
 Standard: Premises clean and orderly
 Means uncluttered with equipment not
stored in corridors,
 Area is neat and well kept
 Spills not left unattended,
 No peeling paint or floor obstructions,
 No visible water leaks or plumbing
problems
133
Proper Ventilation 226 1-31-14
 Standard; There must be proper ventilation,
lighting, and temperature controls,
 In pharmaceutical, patient care and food
preparations
 Proper ventilation in areas with nitrous
oxide, glutaraldehyde, xylene, pentamidine,
or other potentially hazardous substances,
 Isolation rooms comply with laws such
CDC 2007 Isolation Guidelines, OSHA,
NIH, et al,
134
Physical Environment 226
 Temperature, humidity and airflow in the operating
rooms must be maintained within acceptable
standards to inhibit bacterial growth and prevent
infection,
 Including anesthetizing locations where inhalation
anesthesia agents are used
 Excessive humidity in the operating room is
conducive to bacterial growth and compromises the
integrity of wrapped sterile instruments and supplies,
 RH at 35% or greater unless waiver is used of 20% or
greater
 Acceptable standards such as from AORN or the
Facilities Guideline Institute or FGI) should be
incorporated into CAH policy.
135
CMS Memo April 19, 2013
 CMS issues memo related to the relative
humidity (RH)
 AORN use to say temperature maintained
between 68-73 degrees and humidity between
30-60% in OR, PACU, cath lab, endoscopy
rooms and instrument processing areas
 CMS says if no state law can write policy or
procedure or process to implement the waiver
 Waiver allows RH between 20-60%
 In anesthetizing locations- see definition in memo
136
Humidity in Anesthetizing Areas
137
Proper Ventilation & Lighting 1-31-14
138
Physical Environment 226
Must have adequate number of
refrigerators to make sure foods and meds
are stored,
Surveyor will verify these areas are well lit,
Surveyor will verify compliance with
ventilation in patients with TB or other
airborne diseases,
Surveyor will verify food products are
stored under appropriate conditions (time,
temperature, packaging) based on national
sources like USDA and FDA,
139
Emergency Procedures 227
Standard: Assure safety of patients
in non-medical emergencies,
Staff trained in handling
emergencies such as reporting and
extinguishing of fires, evacuations,
et al.,
Report all fires to the state officials,
Will interview staff to make sure
they know what to do in case of a
fire,
140
Physical Environment 227
How do you ensure all personnel are
trained to manage non medical
emergencies?
Ask staff what to do in case of a
tornado, hurricane, earthquake, or
blizzard,
Review staff training documents and
in-service records to confirm training,
141
Physical Environment 228
Standard: Provide for emergency power
and lighting in ED and for battery lamps
or flashlights in other areas,
Must comply with the applicable provisions of
the Life Safety Code,
National Fire Protection Amendments
(NFPA) 101, 2000 Edition and applicable
references such as NFPA-99: Health Care
Facilities, for emergency lighting and
emergency power,
142
Emergency Fuel and Water 229
Standard: Provide for emergency fuel and
water supply (snow bound or flooding),
 Must have system to provide emergency gas and
water as needed to provide care to inpatients and
other persons who may come to the CAH in need
of care,
Includes making arrangements with local
utility companies and others for the provision
of emergency sources of water and gas,
 Source of information on water is FEMA,
 Have a plan for prioritizing their use until adequate
supplies are available,
143
Emergency Preparedness Plan 230
Develop a comprehensive plan to ensure
that the safety and well being of patients are
assured during emergency situations,
 Coordinate with Federal, State, and local
emergency preparedness and health authorities to
identify likely risks for their area (e.g., natural
disasters, bioterrorism threats, disruption of utilities
such as water, sewer, electrical communications,
fuel; nuclear accidents, industrial accidents, and
other likely mass casualties, etc.)
 Develop appropriate responses that will ensure the
safety and well being of patients.
144
CMS Revised Checklist Memo
CMS issues 8 page memo on Feb 28, 2014
Regarding checklist for emergency
preparedness (EP)
Update provides information about patient
tracking, supplies and collaboration
Discusses Oct 24, 2007 memo on EP
 This updated checklist can be found at S&C
Emergency Preparedness Website
http://www.cms.hhs.gov/SurveyCertEmergPr
ep
145
CMS Revised Checklist
146
147
Proposed Changes EP Requirements
CMS publishes proposed rule in the Federal
Register on December 27, 2013
Requires hospitals that accepts Medicare or
Medicaid to adequately plan for disasters
Whether natural or man made
Would have to coordinate with federal, state,
and local emergency preparedness systems
To enhance patient safety during an
emergency
148
Proposed Changes EP Requirements
149
Emergency Preparedness Plan
The following issues should be considered
when developing the comprehensive
emergency plans:
 Differences needed for each location where
the certified CAH operates;
 Special needs of patient populations treated
at the CAH (e.g., patients with psychiatric
diagnosis, patients on special diets, newborns,
etc.);
 Security of patients and walk-in patients;
 Security of supplies from misappropriation;
150
Emergency Preparedness Plan
Pharmaceuticals, food, other supplies and
equipment that may be needed during
emergency/disaster situations;
Communication to external entities if
telephones and computers are not
operating or become overloaded (e.g., ham
radio operators, community officials, other
healthcare facilities if transfer of patients is
necessary, etc.);
Communication among staff within the CAH
itself;
151
Emergency Preparedness Plan
 Qualifications and training needed by
personnel, including healthcare staff, security
staff, and maintenance staff, to implement and
carry out emergency procedures;
 Identification, availability and notification of
personnel that are needed to implement and
carry out the CAH’S emergency plans;
 Identification of community resources,
including lines of communication and names
and contact information for community
emergency preparedness coordinators and
responders;
152
Emergency Preparedness Plan
Provisions for gas, water, electricity
supply if access is shut off to the
community;
Transfer or discharge of patients to
home or other healthcare settings,
Methods to evaluate repairs needed
and to secure various likely materials
and supplies to effectuate repairs.
153
FIRE Inspections 231-233
Must meet LSC of National Fire Protection
Association such as NFPA-99 (231)
CMS can allow state surveyor to apply
state’s fire and safety code if CMS finds that
it adequately protects patients
CMS can waive specific provisions of the
LSC if it would result in unreasonable
hardship
 But only if the waiver does not put patients at
risk
154
FIRE Inspections
234
Maintains written evidence of
regular inspection and
approval by State or local fire
control agencies,
Surveyor will examine copies
of inspection and approval
reports from State and local
fire control agencies,
155
Governing Body 241
Standard; CAH has a governing body or
individual that assumes legal responsibility
for implementing and monitoring P&Ps,
Must have 1 governing body or responsible
person,
Board must determine what categories of
practitioners are eligible for appointment and
reappoint to MS (NP, PA, dentist, CRNA) and
there is written criteria for staff appointments,
Done with advice of MS,
156
Governing Body 241
Must be consistent with state and federal law
requirements,
Board approves MS bylaws and any
revisions
 Surveyor will look for this,
Board responsible for conduct of CAH and
for quality of care to patients,
All patients must be under the care of a
member of the MS
 Or under care of member of MS under their
supervision
157
Governing Body
 Criteria for MS is based on individual
character, competence, training,
experience and judgment,
 Surveyor will look to see Board or written
documentation of person responsible for
CAH,
 Will look to verify that Board has categories
of practitioners for appointment to MS,
 Confirm that Board appoints all members
to the MS,
158
Disclosure
242
CAH discloses the names and addresses of
its owners or those with controlling interest,
Either directly or indirectly has 5% or more
ownership,
Surveyor will look for policy on reporting
changes of ownership,
Need policy on how to reporting changes for
person responsible for operation of hospital
(CEO) to state agency and also for reporting
changes in medical director (243,244),
159
Staffing 250
Standard: CAH has professional staff
that includes one or more physicians,
and may include PA, NP, or CNS,
Need to have organizational chart
which shows names of all MD/DO and
mid-level providers
 PA, NP, or CNS
Surveyor will review work schedules,
160
Staffing 252
Standard: All ancillary staff must be
supervised by professional staff,
Have sufficient staff to take care of
patients
 Emergency services, nursing services, Tag 253,
Will review staffing schedules and daily
census records,
 Make sure answer call lights promptly
 Make sure address monitor that alarms timely
161
Staffing 254
MD, DO, NP, PA, or CNS must be
available at all times to furnish care,
Must show practitioner is available
and shows up when patient presents
to the hospital,
Doesn’t mean they have to be there
24 hours a day,
162
Nurse on Duty 255
Standard: Must have a
RN, CNS, or LPN on
duty whenever there is
one or more inpatients,
Surveyor will review
staff schedules to make
sure,
163
Physician Responsibilities 257
Standard: MD/DO must provide medical
directions and supervision of staff,
Surveyor will make sure is available for
consultation and supervision of staff,
PA or NP participate in developing and
reviewing written P&P (258)
Physicians must periodically review charts
of PA and NP and surveyor will look for
documentation of same (259),
164
Physician Supervision 260 2015
Must have a doctor on staff and must
perform medical oversight,
 Must be present for sufficient period
 No longer says must be present at least
once every two week to provide direction
Will want evidence that the Dr. provides
oversight and is available for consultation or
patient referral,
What evidence the there is periodic review of
patient records by the doctor?
165
Physician Supervision
2015
Periodically reviews and signs records of all
inpatients cared by PA, NP, or CNS
 MD/DO signs records after review completed
 If case is managed by doctor and care given by
non-physician review is not required
Periodically reviews and signs sample of
outpatient records
 Of NP, CNS, PA, or CNM
 ONLY if state law requires review or cosignature or state requires collaborating
physician to sign
166
Physician Supervision
2015
There is no time frame in the rule for the
periodic review of PA or NP for inpatient
CAH must specify a time frame in P&P for the
maximum interval between inpatient reviews
Must take into account the volume and types
of services provided in developing the P&P
4 bed CAH would have different time frame
than 25 bed CAH
Also does CAH have EHR that can be
reviewed and signed off remotely?
167
Physician Present in the CAH 261 2015
MD or DO must be present in the CAH for
sufficient periods of time
 No longer says every two weeks
 To provide medical direction, consultation and
supervision
And is available through radio or telephone or
electronic communication (telemedicine)
 Develop P&P on this and document compliance
CAH with busy ED and large outpatient unit
would expect more frequent visits
168
Physician Present in the CAH 261
Biweekly visit might be burdensome for small
CAH in a remote area with low patient volume
Remember the federal EMTALA law
MD, DO, PA, CNS, or NP must be on call and
available to provide emergency care
Must have list of on-call physicians
Must make sure MD or DO is available via
phone, radio, video conferencing etc to handle
patient emergencies and refer patients to
other facilities
169
PA, NP, CNS 263
Must be members of CAH staff,
Must participate in development and review
of P&P,
Interview them to determine their
participation and knowledge of policies,
Will interview to determine their level of
involvement in development of P&Ps and
make updated,
Policies also need to be consistent with
state standards of practice,
170
Transfer of Patients 267
Standard: Arrange for transfer of
patients who need services that
can not be furnished,
 Must sent the patient’s medical
records,
 Remember EMTALA is a separate
CoP that every CAH must follow,
 Make sure you have a transfer policy
and it should be consistent with
EMTALA,
171
Patient Admission 268
 Standard: Whenever a patient is admitted by
NP, PA, or CNS, a physician on the staff must
be notified,
 CMS requires that Medicare and Medicaid patients
be under the care of a MD/DO if patient has
medical or psych problems that are outside of the
scope of their practice,
 Admitting privileges must be consistent with what
state law allows,
 Surveyor will look to make sure MD/DO monitor
care for any medical problem outside their scope of
practice,
172
Patient Care Policies
2015
Standard: Services are provided in
accordance with appropriate P&P (271)
Provision of Services :Related to P&P and services
and services provided including through contract
(270)
Need P&P governing the healthcare services that
are available
Must follow them in delivering care
Will review policies on healthcare services that are
provided in the CAH
Observe staff delivering care to the patient
173
Patient Care Policies 272 2015
P&P need to be developed by group of
professional staff and include:
 1 MD/DO
 1 or more PA, NP, CNS if on staff (if CAH has
these individuals on their staff)
 Removed requirement for one member is who
not a member of the staff
Removed section that said will interview
CNO to determine role in policy development
Review annually by above and as needed
such as when change in a law
174
Patient Care Policies 272
Must maintain documentation of the P&P
committee’s activity
 Must show evidence that group reviewed all the
P&P at least yearly
 Must reflect any changes made
To review existing and new P&P
Final decision on P&P is made by the board
If the P&P recommendations by the advisory
group are rejected, then board must include
in the record the rational for the change
175
Policies (Scope of Services) 273 2015
Standard: Need P&P on description of services
provided by CAH directly or through contract
 Often called scope of services or provision of care
 Should include statements like “taking complete
medical histories, providing complete physical
examinations, laboratory tests including” (with a
list of tests provided) would satisfy this
requirement,
 Should include arrangements made with Hospital
X for providing the following services with list of
specialized diagnostic and lab testing,
176
Emergency Medical Services 274 2015
Need P&P for providing emergency
medical services
Policies should show how the CAH would
meet all of its emergency services
requirements
Will look at what equipment, supplies,
medications, and blood is available on site
How does CAH coordinate with local EMS?
What type of staff are available to provide
care in the ED?
177
Guideline for Medical Management 275 2015
Need guidelines on managing health
problems that include when medical
consultation or referral is needed
Need written guidelines on maintaining
medical records and procedure for periodic
review and evaluation of the services
provided at the CAH
 Such as general instructions or protocols
on how to medically manage the patient’s
health problems commonly seen in the
CAH
178
Medical Management 275
Needs to include P&P on the scope of
medical acts which may be done by PA,
CNS, or NP
When should physician be consulted or
referred outside the CAH?
What medical procedures can PA or NP
do?
Guidelines need to describe the medical
conditions, signs or development that require
consultation,
179
The End! Questions??
Sue Dill Calloway RN, Esq.
CPHRM, CCMSCP
AD, BA, BSN, MSN, JD
President
Board Member
Emergency Medicine Patient
Safety Foundation
www.empsf.org
614 791-1468
[email protected]
180
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